Effects of immediate versus gradual nicotine reduction in cigarettes on biomarkers of biological effects

Dorothy K. Hatsukami; Xianghua Luo; Alisa K. Heskin; Mei Kuen Tang; Steven G. Carmella; Joni Jensen; Jason D. Robinson; Ryan Vandrey; David J. Drobes; Andrew A. Strasser; Mustafa al'Absi; Scott Leischow; Paul M. Cinciripini; Joseph Koopmeiners; Joshua Ikuemonisan; Neal L. Benowitz; Eric C. Donny; Stephen S. Hecht

doi:10.1111/add.14695

Effects of immediate versus gradual nicotine reduction in cigarettes on biomarkers of biological effects

Dorothy K. Hatsukami, Xianghua Luo, Alisa K. Heskin, Mei Kuen Tang, Steven G. Carmella, Joni Jensen, Jason D. Robinson, Ryan Vandrey, David J. Drobes, Andrew A. Strasser, Mustafa al'Absi, Scott Leischow, Paul M. Cinciripini, Joseph Koopmeiners, Joshua Ikuemonisan, Neal L. Benowitz, Eric C. Donny, Stephen S. Hecht

Research output: Contribution to journal › Article › peer-review

4 Scopus citations

Abstract

Aim: A previous study showed significantly greater reductions in number of cigarettes smoked and biomarkers of toxicant and carcinogen exposure in smokers assigned to immediate reduction of nicotine in cigarettes to very low levels versus gradually over time or continued smoking of normal nicotine content cigarettes. This study examines the effects of these approaches on selected biomarkers associated with harmful biological effects. Design: Three-arm, randomized controlled trial. Setting: Ten United States academic institutional sites. Participants: Daily smokers uninterested in quitting smoking with a mean age of 45.1 [standard deviation (SD) = 13.4)] years and smoking 17.1 (SD = 8.5) cigarettes/day; 43.9% (549 of 1250) female; 60.6% (758 of 1250) white ethnicity. Interventions: (1) Smoking cigarettes where nicotine content was immediately reduced to very low levels (n = 503); (2) smoking cigarettes where nicotine content was gradually reduced, with dose changes occurring monthly (n = 498); and (3) continued smoking with normal nicotine content cigarettes (n = 249). Measurements: Smokers were assessed at baseline while smoking their usual brand cigarettes, and again at 4, 8, 12, 16 and 20 weeks. Outcomes were areas under the concentration time curve (AUC) for the period of study of biomarkers of inflammation, oxidative stress and hematological parameters. Findings: No consistent significant differences were observed across groups (Bayes factors showing data to be insensitive), with the only exception being red blood cell size variability, which was observed to be lower in the immediate versus gradual nicotine reduction [mean difference = −0.11; 95% confidence interval (CI) = –0.18, −0.04, P = 0.004] and normal nicotine control groups (mean difference = − 0.15, 95% CI = –0.23, −0.06, P = 0.001). Conclusion: It remains unclear whether switching to very low nicotine cigarettes leads to a short-term reduction in biomarkers of tobacco-related harm.

Original language	English (US)
Pages (from-to)	1824-1833
Number of pages	10
Journal	Addiction
Volume	114
Issue number	10
DOIs	https://doi.org/10.1111/add.14695
State	Published - Oct 1 2019
Externally published	Yes

Keywords

Biomarkers of biological effects
hematological parameters
immediate versus gradual nicotine reduction
inflammation
oxidative stress
reduced nicotine content cigarettes

ASJC Scopus subject areas

Medicine (miscellaneous)
Psychiatry and Mental health

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10.1111/add.14695

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Hatsukami, D. K., Luo, X., Heskin, A. K., Tang, M. K., Carmella, S. G., Jensen, J., Robinson, J. D., Vandrey, R., Drobes, D. J., Strasser, A. A., al'Absi, M., Leischow, S., Cinciripini, P. M., Koopmeiners, J., Ikuemonisan, J., Benowitz, N. L., Donny, E. C., & Hecht, S. S. (2019). Effects of immediate versus gradual nicotine reduction in cigarettes on biomarkers of biological effects. Addiction, 114(10), 1824-1833. https://doi.org/10.1111/add.14695

Hatsukami, DK, Luo, X, Heskin, AK, Tang, MK, Carmella, SG, Jensen, J, Robinson, JD, Vandrey, R, Drobes, DJ, Strasser, AA, al'Absi, M, Leischow, S, Cinciripini, PM, Koopmeiners, J, Ikuemonisan, J, Benowitz, NL, Donny, EC & Hecht, SS 2019, 'Effects of immediate versus gradual nicotine reduction in cigarettes on biomarkers of biological effects', Addiction, vol. 114, no. 10, pp. 1824-1833. https://doi.org/10.1111/add.14695

@article{c7aeefdbdd6e4b0d861e74da15fef095,

title = "Effects of immediate versus gradual nicotine reduction in cigarettes on biomarkers of biological effects",

abstract = "Aim: A previous study showed significantly greater reductions in number of cigarettes smoked and biomarkers of toxicant and carcinogen exposure in smokers assigned to immediate reduction of nicotine in cigarettes to very low levels versus gradually over time or continued smoking of normal nicotine content cigarettes. This study examines the effects of these approaches on selected biomarkers associated with harmful biological effects. Design: Three-arm, randomized controlled trial. Setting: Ten United States academic institutional sites. Participants: Daily smokers uninterested in quitting smoking with a mean age of 45.1 [standard deviation (SD) = 13.4)] years and smoking 17.1 (SD = 8.5) cigarettes/day; 43.9% (549 of 1250) female; 60.6% (758 of 1250) white ethnicity. Interventions: (1) Smoking cigarettes where nicotine content was immediately reduced to very low levels (n = 503); (2) smoking cigarettes where nicotine content was gradually reduced, with dose changes occurring monthly (n = 498); and (3) continued smoking with normal nicotine content cigarettes (n = 249). Measurements: Smokers were assessed at baseline while smoking their usual brand cigarettes, and again at 4, 8, 12, 16 and 20 weeks. Outcomes were areas under the concentration time curve (AUC) for the period of study of biomarkers of inflammation, oxidative stress and hematological parameters. Findings: No consistent significant differences were observed across groups (Bayes factors showing data to be insensitive), with the only exception being red blood cell size variability, which was observed to be lower in the immediate versus gradual nicotine reduction [mean difference = −0.11; 95% confidence interval (CI) = –0.18, −0.04, P = 0.004] and normal nicotine control groups (mean difference = − 0.15, 95% CI = –0.23, −0.06, P = 0.001). Conclusion: It remains unclear whether switching to very low nicotine cigarettes leads to a short-term reduction in biomarkers of tobacco-related harm.",

keywords = "Biomarkers of biological effects, hematological parameters, immediate versus gradual nicotine reduction, inflammation, oxidative stress, reduced nicotine content cigarettes",

author = "Hatsukami, {Dorothy K.} and Xianghua Luo and Heskin, {Alisa K.} and Tang, {Mei Kuen} and Carmella, {Steven G.} and Joni Jensen and Robinson, {Jason D.} and Ryan Vandrey and Drobes, {David J.} and Strasser, {Andrew A.} and Mustafa al'Absi and Scott Leischow and Cinciripini, {Paul M.} and Joseph Koopmeiners and Joshua Ikuemonisan and Benowitz, {Neal L.} and Donny, {Eric C.} and Hecht, {Stephen S.}",

note = "Publisher Copyright: {\textcopyright} 2019 Society for the Study of Addiction",

year = "2019",

month = oct,

day = "1",

doi = "10.1111/add.14695",

language = "English (US)",

volume = "114",

pages = "1824--1833",

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T1 - Effects of immediate versus gradual nicotine reduction in cigarettes on biomarkers of biological effects

AU - Hatsukami, Dorothy K.

AU - Luo, Xianghua

AU - Heskin, Alisa K.

AU - Tang, Mei Kuen

AU - Carmella, Steven G.

AU - Jensen, Joni

AU - Robinson, Jason D.

AU - Vandrey, Ryan

AU - Drobes, David J.

AU - Strasser, Andrew A.

AU - al'Absi, Mustafa

AU - Leischow, Scott

AU - Cinciripini, Paul M.

AU - Koopmeiners, Joseph

AU - Ikuemonisan, Joshua

AU - Benowitz, Neal L.

AU - Donny, Eric C.

AU - Hecht, Stephen S.

PY - 2019/10/1

Y1 - 2019/10/1

N2 - Aim: A previous study showed significantly greater reductions in number of cigarettes smoked and biomarkers of toxicant and carcinogen exposure in smokers assigned to immediate reduction of nicotine in cigarettes to very low levels versus gradually over time or continued smoking of normal nicotine content cigarettes. This study examines the effects of these approaches on selected biomarkers associated with harmful biological effects. Design: Three-arm, randomized controlled trial. Setting: Ten United States academic institutional sites. Participants: Daily smokers uninterested in quitting smoking with a mean age of 45.1 [standard deviation (SD) = 13.4)] years and smoking 17.1 (SD = 8.5) cigarettes/day; 43.9% (549 of 1250) female; 60.6% (758 of 1250) white ethnicity. Interventions: (1) Smoking cigarettes where nicotine content was immediately reduced to very low levels (n = 503); (2) smoking cigarettes where nicotine content was gradually reduced, with dose changes occurring monthly (n = 498); and (3) continued smoking with normal nicotine content cigarettes (n = 249). Measurements: Smokers were assessed at baseline while smoking their usual brand cigarettes, and again at 4, 8, 12, 16 and 20 weeks. Outcomes were areas under the concentration time curve (AUC) for the period of study of biomarkers of inflammation, oxidative stress and hematological parameters. Findings: No consistent significant differences were observed across groups (Bayes factors showing data to be insensitive), with the only exception being red blood cell size variability, which was observed to be lower in the immediate versus gradual nicotine reduction [mean difference = −0.11; 95% confidence interval (CI) = –0.18, −0.04, P = 0.004] and normal nicotine control groups (mean difference = − 0.15, 95% CI = –0.23, −0.06, P = 0.001). Conclusion: It remains unclear whether switching to very low nicotine cigarettes leads to a short-term reduction in biomarkers of tobacco-related harm.

AB - Aim: A previous study showed significantly greater reductions in number of cigarettes smoked and biomarkers of toxicant and carcinogen exposure in smokers assigned to immediate reduction of nicotine in cigarettes to very low levels versus gradually over time or continued smoking of normal nicotine content cigarettes. This study examines the effects of these approaches on selected biomarkers associated with harmful biological effects. Design: Three-arm, randomized controlled trial. Setting: Ten United States academic institutional sites. Participants: Daily smokers uninterested in quitting smoking with a mean age of 45.1 [standard deviation (SD) = 13.4)] years and smoking 17.1 (SD = 8.5) cigarettes/day; 43.9% (549 of 1250) female; 60.6% (758 of 1250) white ethnicity. Interventions: (1) Smoking cigarettes where nicotine content was immediately reduced to very low levels (n = 503); (2) smoking cigarettes where nicotine content was gradually reduced, with dose changes occurring monthly (n = 498); and (3) continued smoking with normal nicotine content cigarettes (n = 249). Measurements: Smokers were assessed at baseline while smoking their usual brand cigarettes, and again at 4, 8, 12, 16 and 20 weeks. Outcomes were areas under the concentration time curve (AUC) for the period of study of biomarkers of inflammation, oxidative stress and hematological parameters. Findings: No consistent significant differences were observed across groups (Bayes factors showing data to be insensitive), with the only exception being red blood cell size variability, which was observed to be lower in the immediate versus gradual nicotine reduction [mean difference = −0.11; 95% confidence interval (CI) = –0.18, −0.04, P = 0.004] and normal nicotine control groups (mean difference = − 0.15, 95% CI = –0.23, −0.06, P = 0.001). Conclusion: It remains unclear whether switching to very low nicotine cigarettes leads to a short-term reduction in biomarkers of tobacco-related harm.

KW - Biomarkers of biological effects

KW - hematological parameters

KW - immediate versus gradual nicotine reduction

KW - inflammation

KW - oxidative stress

KW - reduced nicotine content cigarettes

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Effects of immediate versus gradual nicotine reduction in cigarettes on biomarkers of biological effects

Abstract

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